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DECLARATIONOFCONFORMITY
Nameandaddressofthefirm
Wedeclareunderoursoleresponsibilitythat
themedicaldevice
Name,typeormodel,batchorserialnumber,possiblysourcesandnumberofitems
ofclass
accordingtoannexIXofdirect.93/42/EEC
meetsalltheprovisionsofthedirective93/42/EEC(or90/385/EEC)whichapplytoit.
Appliedharmonisedstandards,national
standardsorothernormative
documents
Conformityassessmentprocedure
NotifiedBody(ifconsulted)
Place,dateNameandfunction
MDDAgreement
We,«Company»
(hereinafterreferredtoasCompanyA)
and«EUrep»
(hereinafterreferredtoasCompanyB)
haveagreedasfollowswithregardtothehandlingofallproducts(hereinaftercalled
“Products”)manufacturedandsuppliedbyCompanyAtoCompanyBinorderto
complytotherequirementssetoutintheCOUNCILDIRECTIVE93/42/EEC
ConcerningMedicalDevices(MDD)and“GuidelinesonaMedicalDevicesVigilance
System”.
1.Appointment
CompanyAherebyappointsCompanyB,whoacceptssuchappointment,asa
representativeforthe“BusinessArea”and“ProductCategories”setoutin
AppendixA.Theresponsibilityofbothpartiesareasstatedhereafter.
2.ClaimHandling
CompanyBshallberesponsibletorecordallcustomerandmarketclaimsrelated
totheproductsofCompanyAandtransfertheinformationtoCompanyAupon
receivingofsuchclaims.
3.AccidentHandling
Onreceivinginformationofanincident(accident)oranearincident,asdefinedin
theMDD93/42/EECandMEDDEV2.12“GuidelinesonaMedicalDevices
VigilanceSystem”,thefollowingproceduresshallbeapplied:
CompanyBshallreportoccurrenceofanincide
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